Comments:
-The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses depending on the individual patient response.
-Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Use: Narcolepsy treatment

Usual Adult Dose for Obesity

IMMEDIATE-RELEASE ORAL TABLET:
-Initial Dose: 5 mg orally 30 to 60 minutes before each meal
-Maximum Dose: 30 mg orally per day in divided doses
-Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

Age 12 Years and Older:
-Initial Dose: 10 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:
-The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses depending on the individual patient response.
-Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.
-Narcolepsy rarely occurs in children under 12 years of age.

Use: Narcolepsy treatment

Usual Pediatric Dose for Obesity

IMMEDIATE-RELEASE ORAL TABLET:Age 12 Years and Older:
-Initial Dose: 5 mg orally 30 to 60 minutes before each meal
-Maximum Dose: 30 mg orally per day in divided doses
-Duration of Therapy: Should not exceed a few weeks

Use: Short-term adjunct in a weight reduction regimen based on caloric restriction; for patients in whom obesity is refractory to alternative therapy (e.g., repeated diets, group programs, other drugs).

Age 6 to 17 Years:
-Initial Dose: 5 mg orally 1 or 2 times a day
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.
-Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.

EXTENDED-RELEASE ORAL SUSPENSION:Age 6 to 17 Years:
-Initial Dose: 2.5 or 5 mg orally once a day in the morning
-Maintenance Dose: Dose may be raised in increments of 2.5 to 10 mg per day every 4 to 7 days until optimal response is obtained.
-Maximum Dose: 20 mg orally per day

Comments:
-IMMEDIATE-RELEASE: The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-EXTENDED-RELEASE: When switching from other amphetamine products, this product should be titrated using the usual dosing schedule after the other amphetamine product is discontinued.
-EXTENDED-RELEASE: Substituting this product for other amphetamine products should not be done because of different amphetamine base compositions and differing pharmacokinetic profiles.
-EXTENDED-RELEASE: The bottle should be shaken before each dose, and an oral dosing syringe or other suitable measuring device should be used.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD), a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:IMMEDIATE-RELEASE ORAL TABLET:
-Due to the high abuse potential, this drug should be prescribed/dispensed sparingly and particular attention should be paid to subjects possibly obtaining this drug for non-therapeutic use or distribution to others.
-Administering this drug for prolonged periods of time should be avoided as it may lead to drug dependence.
-Drug misuse may cause sudden death and serious cardiovascular adverse events.EXTENDED-RELEASE ORAL SUSPENSION:
-CNS stimulants including this drug, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence.
-The risk of abuse potential should be assessed prior to prescribing, and signs of abuse and dependence should be monitored during therapy.

Long-term effects of this drug in children have not been established. Safety and efficacy for use as an anorectic agent have not been established in patients younger than 12 years or as treatment for ADHD in children younger than 3 years for the immediate-release oral tablet or younger than 6 years for the extended-release oral suspension.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration Advice:
-Regardless of indication, this drug should be administered at the lowest effective dose and dosage should be individualized according to the needs and responses of the patient.
-Late evening doses should be avoided because of resulting insomnia.
-This drug can be taken with or without food.
-Where possible, drug administration should be interrupted occasionally to determine if continued therapy is required.

Storage Requirements:
-This drug should be stored between 20 to 25 degrees Celsius (68 to 77 Fahrenheit) and dispensed in a well-closed container.

General:
-Racemic amphetamine differs from dextroamphetamine (d-isomer of racemic amphetamine) in that the l-isomer is more potent than the d-isomer in cardiovascular activity but much less potent in causing CNS excitatory effects, and the racemic mixture is less effective as an appetite suppressant.
-Individual patient response to amphetamines varies widely: toxic symptoms can occur at doses as low as 2 mg but are rare with doses of less than 15 mg; 30 mg can produce severe reactions yet doses of 400 to 500 mg are not necessarily fatal.
-The extended-release oral suspension formulation contains both immediate-release and extended-release components.
-The extended-release oral suspension contains d-amphetamine and l-amphetamine in a ratio of 3.2 to 1.
-Overdosage: Management is largely symptomatic and includes gastric lavage and sedation with a barbiturate; IV phentolamine has been suggested for acute severe hypertension, and chlorpromazine can antagonize the central stimulant effects.

Patient Advice:
-When taking the extended-release oral suspension, wash the oral dosing measuring device after each use.
-Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.
-Avoid drinking alcohol during treatment.
-Contact your healthcare provider if you experience any of the following on your fingers or toes during treatment: unexplained wounds, new numbness, pain, skin color change, or temperature sensitivity.
-If a take-back program or authorized collectors are not available, dispose of this drug by mixing it with an undesirable, nontoxic substance and place it in a sealed plastic bag in the household trash.
-You should not use this drug to combat fatigue or to replace rest.